BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211832 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-39638
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER CALLED FOR ASSISTANCE WITH HER BLOOD GLUCOSE VALUE NOT TRANSFERRING TO THE INSULIN PUMP. DURING TROUBLESHOOTING, THE CUSTOMER REPORTED THAT SHE HAD BEEN OFF OF THE INSULIN PUMP FOR OVER A MONTH DUE TO A HOSPITALIZATION. CUSTOMER REPORTED THAT SHE OVER CORRECTED FOR A HIGH BLOOD GLUCOSE OF 370MG/DL THE NIGHT BEFORE THE HOSPITALIZATION. CUSTOMER STATED THAT HER BLOOD GLUCOSE MUST HAVE RAN REALLY LOW WHERE SHE FELL OFF HER BED AND BROKE HER NECK. CUSTOMER REPORTED THAT SHE HAD BEEN IN THE HOSPITAL FOR THE PAST MONTH CARING FOR HER BROKEN NECK. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692058 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization